Section 02 · Monograph
Fremanezumab
Reviewed Nov 2026FDA label
AjovyCGRP mAb · injectable
- Forms
- SC syringe: 225mg/1.5mL
- Dose
- 225mg mo. or 675mg quarterly
- MOA
- Binds CGRP ligand
Indications
- Preventive treatment of migraine in adultsFDA-labeled
- Preventive treatment of episodic migraine in pediatric patients 6-17 years of age weighing ≥45 kgFDA-labeled
Mechanism of Action
- Humanized IgG2a monoclonal antibody
- Binds directly to the CGRP LIGAND (calcitonin gene-related peptide, both alpha and beta forms) and blocks its binding to the CGRP receptor
- Prevents CGRP-mediated receptor activation without binding the receptor itself — mechanistically distinct from receptor-antagonist antibodies such as erenumab
Full Dosing
Adult / usual
- 225 mg subcutaneously once monthly, OR
- 675 mg subcutaneously once every 3 months (quarterly), administered as three consecutive 225 mg injections
- Administer into the abdomen, thigh, or upper arm; allow prefilled syringe/autoinjector to reach room temperature (~30 minutes) before injection
Renal
- No dose adjustment established or required for renal or hepatic impairment
Pediatric
- Pediatric patients (6-17 years, ≥45 kg): 225 mg once monthly
Contraindications
- Serious hypersensitivity to fremanezumab-vfrm or any excipient
Drug Interactions
- Not metabolized by cytochrome P450 enzymes; interactions with CYP substrates, inhibitors, or inducers are unlikely
- No formal drug interaction studies have identified clinically significant interactions
Adverse Effects
- Injection site reactions (pain, induration, erythema) — most common adverse reaction, occurring in ~40-45% of patients
- Hypersensitivity reactions including anaphylaxis and angioedema (postmarketing)
- Severe constipation with complications requiring hospitalization or surgery (postmarketing)
- New-onset or worsening hypertension (postmarketing)
- Raynaud's phenomenon (postmarketing)
Monitoring Parameters
- Signs/symptoms of hypersensitivity (onset ranging from hours to one month after injection)
- Bowel function/severe constipation
- Blood pressure for new-onset or worsening hypertension
- Signs/symptoms of Raynaud's phenomenon; discontinue if it develops
Pregnancy & Lactation
- Pregnancy: no adequate human data; animal studies showed no adverse effects at plasma exposures greater than clinical exposure; as an IgG antibody, placental transfer increases with gestational age
- Pregnancy exposure registry available (1-833-927-2605 or www.tevamigrainepregnancyregistry.com)
- Lactation: no data on presence in human milk, effects on the breastfed infant, or effects on milk production; consider benefits of breastfeeding alongside the mother's clinical need for AJOVY